The primary objective of this study is to provide expanded access of S-nitrosylation therapy for the treatment of bronchopulmonary dysplasia
Open label study with 20 participants, open-label, with block dose escalation of 3 subjects/dose (0.5 mL/kg of 0.25 mM, 0.5 mM, or 1 mM). A minimum of seven days of surveillance will separate dosing blocks. An additional 11 subjects will be enrolled at the maximum 1 mM block (5x10-7 moles/kg). The primary outcomes are safety during 30 minutes of inhalation, and for 4 hours after inhalation, as measured by occurrence of adverse events related to the treatment + time period \[during administration and tracked for next 7 days\].
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Intervention will be 30 minutes of inhaled GSNO agent in enrollment blocks of three subjects/dose (0.5 mL/kg of 0.25 mM, 0.5 mM, or 1 mM) to infants.
University Hospitals Cleveland Medical Center Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Treatment Emergent Adverse Events
Occurrence of \>grade 3 adverse events related to the treatment
Time frame: 7 days
S-nitrosoglutathione change
Percent change in S-nitrosoglutathione pre/post treatment
Time frame: 30 minutes
Change in oxygen saturation index
Percent change in oxygen saturation index (O.S.I.) pre/post treatment. oxygen saturation index \[O.S.I. = (FiO2) x (mean airway pressure) x 100 / (SpO2)\]. High OSI scores indicate worse respiratory failure (high OSI = bad, low OSI = good).Scale range: zero - infinity
Time frame: 4 hours
Change in GSNO catabolism pre/post treatment
Percent change in GSNO catabolism pre/post treatment
Time frame: 30 minutes
Intermittent hypoxemia as measured by oxygen saturation post treatment
Incidence, duration, and nadirs of intermittent hypoxemia (SpO2 \<80%) as measured by oxygen saturation parameters post treatment
Time frame: 4 hours
Ventilator parameters post treatment
Change in ventilator parameters post treatment
Time frame: 4 hours
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